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FDA 510(k)

VERSYO.DIRECT

K-Number: K043295 · 2005-01-05

ApplicantHeraeus Kulzer, Inc.
Decision Date2005-01-05
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VERSYO.DIRECT is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 2005-01-05 under 510(k) number K043295. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSYO.DIRECT?

VERSYO.DIRECT is a medical device that received FDA 510(k) clearance on 2005-01-05. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K043295.

When did VERSYO.DIRECT receive FDA 510(k) clearance?

VERSYO.DIRECT received FDA 510(k) clearance on 2005-01-05, under 510(k) number K043295.

Who is the listed applicant for VERSYO.DIRECT?

The FDA 510(k) record lists Heraeus Kulzer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSYO.DIRECT?

The FDA product code for VERSYO.DIRECT is EBI.

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Other records listing Heraeus Kulzer, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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